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A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis
NCT06527404 · View on ClinicalTrials.gov ↗
Study Summary
The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rocatinlimab
Study Locations (20)
Florida
- Direct Helpers Research Center — Hialeah
- Southern Clinical Research — Miami
- University of Miami Hospital — Miami
- Miami Dermatology and Laser Institute — Miami
- Wellness Clinical Research — Miami Lakes
- Clinical Research Trials of Florida Inc — Tampa
- Olympian Clinical Research - Tampa — Tampa
California
- First OC Dermatology — Fountain Valley
- Los Angeles Universal Research Center — Los Angeles
- Paradigm Clinical Research Center Inc — San Diego
- Wolverine Clinical Trials — Santa Ana
Ohio
- Optima Research — Boardman
- University Hospitals Cleveland Medical Center — Cleveland
- Wright State Physicians — Fairborn
Alabama
- University of Alabama at Birmingham — Birmingham
Georgia
- Emory University — Atlanta
Illinois
- Endeavor Health Clinical Trials Center — Skokie
Indiana
- The Indiana Clinical Trials Center PC — Plainfield
Michigan
- Revival Research Institute, LLC — Troy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 469 participants |
| Start Date | 2024-07-18 |
| Est. Completion | 2027-01-17 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06527404
The ClinicalTrials.gov registry entry for NCT06527404 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 469 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prurigo Nodularis appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06527404 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06527404 about?
NCT06527404 is a clinical study titled "A Phase 3, Placebo-controlled, Double-blind Study Assessing Rocatinlimab in Prurigo Nodularis". The main objective of the study will be to evaluate the efficacy of rocatinlimab compared with placebo at week 24 on the patient-reported outcome (PRO) measure of pruritus and overall clinical assessment score (US only).
What is the current status of trial NCT06527404?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 469 participants. The study started on 2024-07-18. Estimated completion is 2027-01-17.
What conditions does trial NCT06527404 study?
This clinical trial studies the following conditions: Prurigo Nodularis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06527404?
The interventions under investigation include: Placebo (DRUG), Rocatinlimab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06527404?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06527404 being conducted?
This trial has 20 study locations across Alabama, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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